Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DEFERASIROX
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
DEFERASIROX
28Tablet Tablets; 84Tablet Tablets
NOVARTIS PHARMA STEIN AG
Novartis Page 2 Malaysian Package Leaflet 24-Jul-2019 Exjade EXJADE Iron chelating agent. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM(S) Dispersible tablets. ACTIVE SUBSTANCE(S) Each dispersible tablet contains 125 mg / 500 mg deferasirox as active substance. Certain dosage strengths may not be available in all countries. EXCIPIENTS Lactose monohydrate; crospovidone; microcrystalline cellulose; povidone (K30); sodium lauryl sulphate; silicon dioxide; magnesium stearate DESCRIPTION Exjade 125mg: Off white, round, flat, beveled edge and imprint (debossment) “J 125” on one side and “NVR” on the other. Exjade 500mg: White to slightly yellow, round, flat tablet with bevelled edge and imprint (debossment) “J 500” on one side, “NVR” on the other. INDICATIONS Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in adult and pediatric patients (aged 2 years and over). Exjade is also indicated for the treatment of chronic iron overload in patients with non- transfusion-dependent thalassemia syndromes aged 10 years and over. DOSAGE REGIMEN AND ADMINISTRATION TRANSFUSIONAL IRON OVERLOAD DOSAGE REGIMEN It is recommended that therapy with Exjade be started after the transfusion of approximately 20 units (about 100 mL/kg) of packed red blood cells or when there is evidence from clinical monitoring that chronic iron overload is present (e.g. serum ferritin >1,000 microgram/L). Doses (in mg/kg) must be calculated and rounded to the nearest whole tablet size. The goals of iron chelation therapy are to remove the amount of iron administered in transfusions and, as required, to reduce the existing iron burden. The decision to remove Novartis Page 3 Malaysian Package Leaflet 24-Jul-2019 Exjade accumulated iron should be individualized based on anticipated clinical benefit and risks of chelation therapy. For patients who are currently on chelation therapy with Exjade film-coated tablets and switching to Exjade dispersible tablets, the dose of Exj Olvassa el a teljes dokumentumot